Pages

Thursday, June 30, 2011

Yesterday's news that the FDA hearing went south and Avastin was not going to be approved for use for advanced stage breast cancer struck fear in the hearts of all the women who are currently benefiting from the drug.

What did this mean? Where will they turn? Would insurance companies still cover it on a compassionate basis?

A major step forward happened today: Medicare announced it would continue covering it. You can read about it here.

Insurance companies: Follow their lead. DO NOT STOP COVERING AVASTIN FOR WOMEN WITH BREAST CANCER.

Tuesday, June 28, 2011

Shocking news hit the airwaves today as a very large, local breast cancer organization was taken down because of fraud. They raised millions of dollars and none of it went to women with breast cancer. They spent every dime on raising more money for themselves and paying themselves huge salaries. Basically, they hijacked breast cancer to make a quick, sleazy buck.

As someone who has had breast cancer twice, let me tell you this makes me more sick than any chemo I ever did. As someone who runs a non profit organization for women with breast cancer on Long Island, I am doubly disgusted. If you knew how hard it is to raise any money, much less the millions these folks raised, you would understand.

The No Surrender Breast Cancer Foundation has vital, legitimate programs that literally save women's lives. We also get women through their breast cancer in one, strong, self-advocating, hopeful piece.

I am writing today to let you know that we do not have salaries. We do not have expensive office space. We do not drive fancy cars. Why? Because we are doing this for you. One hundred percent of your donation dollar goes directly to the foundation's programs and helping women. We run a very tight ship and as the economy tanks even further and the donations are becoming more scarce for more and more charities, it is not easy to keep things running. BUT WE DO. Because we are committed to this cause and we believe in what we do. We know how many women we have helped and how many young women's lives may be saved by our Before Forty program.

I just wanted you to know that you can feel secure in supporting us because in reality, you are directly supporting women with breast cancer. And that is why we exist. For You.

LI breast cancer charity sued on misuse of donations

June 28, 2011 by TED PHILLIPS / ted.phillips@newsday.com

A Long Island charity that collected millions of dollars of donations spent almost none of it on the breast cancer services and research for which it raised the money, the State Attorney General Eric Schneiderman alleged in a complaint filed Tuesday.

The St. James-based Coalition Against Breast Cancer spent most of its money on fundraising, according to the complaint, which was filed in New York State Supreme Court in Suffolk. Over the past five years the organization raised $9.1 million, but spent less than 4 percent, or $364,000, on charitable programs, the attorney general's office said.
Schneiderman charged the organization along with the for-profit fundraiser Campaign Center Inc. and key personnel with violations of state not-for-profit and charitable solicitation laws. The suit aims to shut the organization down.

"By using a charity as a personal cash machine, the Coalition Against Breast Cancer and Campaign Center shamelessly exploited New Yorkers' natural sympathies and generosity," Schneiderman said in a news release. "Instead of benefiting breast cancer victims and their families, millions of dollars were misused for personal benefit."

In 2009, the organization gave out $57,481 in grants, less the $73,500 salary of its director of development, Debra Koppleman, according to tax filings. That year the organization raised $1.5 million while spending $1.1 million on fundraising. The charity has been run out of the home of its treasurer, Andrew Smith, who was named in the suit along with Koppleman and Patricia Scott, a director at the organization.

The suit also names Garrett Morgan, the owner of Campaign Center, which Schneiderman said engaged in fraudulent fundraising tactics while keeping 85 cents of every dollar it raised. Morgan was an associate of nonprofit's founder and ran its fundraising operations, according to the attorney general's office.

Schneiderman alleges that Smith and Morgan launched the organization and its fundraising program together in 1995 and that it served them as a cash machine rather than help women with breast cancer.
A person answering the phone at the organization identified himself as Smith and hung up the phone when a reporter identified himself. Morgan declined to comment.

The organization has no connection with the Manhasset Women's Coalition Against Breast Cancer.

Monday, June 20, 2011

There's No 'Average' Cancer Patient

What the late Stephen Jay Gould could teach the FDA.

By GREGORY CONKO

On June 28, the Food and Drug Administration (FDA) will hold a hearing to decide the fate of Avastin, a drug taken by thousands of women fighting late-stage breast cancer. Many of these women have pleaded for continued access to the drug, which they consider a matter of life and death.
But this case is really about what will guide decisions on treatment options—the best judgment of doctors and their patients, or the policy preferences of the FDA.

Last year, the FDA began the process of revoking Avastin's approval for breast cancer. Some leading oncologists applauded the decision, arguing that, for the average patient, Avastin doesn't work very well and has significant side effects.

Patient advocates and thousands of women who credit their survival to Avastin argue that it's unfair for the FDA to remove one of the few available options for patients diagnosed with terminal cancer. They're right.

Avastin originally hit the market in 2004 to treat other cancers, and in 2008 the FDA conditionally approved it for breast cancer. Initial testing showed that, on average, Avastin didn't lengthen patients' overall survival time. But it did slow tumor growth, giving many patients a longer "progression-free" survival. What this means is that dying patients get a precious few extra months of quality time they can spend with family and friends, travel rather than being confined to a bed, or get their personal effects in order.

A small percentage of patients taking Avastin have been cured of their breast cancer. But the drug's permanent approval hinged on the results of two additional clinical studies focusing on the progression-free survival end-point experienced by the majority of Avastin users. As before, neither study found an increase in overall survival, but they did record modest gains in progression-free survival—about five and a half months longer than those on the alternative treatment. That wasn't enough for the FDA, so the agency moved to revoke Avastin's approval for breast cancer last July.

The weakness of the FDA's reasoning here is that averages ignore that individual patients respond differently to treatments. Particularly with life-threatening illnesses, where the downside of any treatment is relatively small, average or median survivability too often masks the fact that some patients respond very well.

When well-known scientist Stephen Jay Gould was diagnosed with a rare form of lung cancer in July 1982, he was told the diagnosis meant a median survival time of just eight months. His doctor gave up on him. But he lived another 20 years.

"Means and medians are the abstractions," he wrote in Discover magazine in 1985. "Therefore, I looked at the mesothelioma statistics quite differently—and not only because I am an optimist . . . but primarily because I know that variation itself is the reality."

Like Gould's doctor, the FDA and its technocratic supporters are giving up on breast cancer patients because of their slavish obsession with median response rates. Everyone can agree that, on average, Avastin does not extend most patients' life expectancy. But some patients have responded incredibly well, living years longer than expected. The medical community calls them "super responders." Statisticians might describe them as "outliers." But they're real people, alive because of Avastin.

In a recent letter to USA Today, Shannon Morgan of Charlotte, N.C., wrote: "I've been on Avastin nearly three years, am able to work full-time and lead an active life. I'm not alone. Every drug has side effects. The FDA seems to forget that the primary side effect of Stage 4 cancer is death."

Avastin is expensive: $56,000 to $96,000 per year. The expected value of treatment for any given patient—the abstract "median"—seems small, so a private health plan may understandably balk at paying such a tab. But cost-effectiveness calculation isn't the FDA's job, and in fact the law forbids the agency from considering anything but a product's safety and effectiveness while it's evaluated.
What is the logic of keeping terminally ill patients from potential treatments? Can't they at least go down fighting?

I wrote to them because young women, particularly African American women, get diagnosed with Triple Negative Breast Cancer before the age of forty. If they wait until forty for their first screening, it can be too late, and often is. I explained what the Before Forty Initiative does and how it saves lives. I even quoted studies from their own site that African American women disproportionately develop TNBC over Caucasian women. Here are excerpts from the request:

“...we need help with our most important program, the Before Forty Initiative. My first cancer was found at age 39 only because I had baseline screening starting at age 35. Because my cancer was TNBC, I was very lucky that it was found before it spread. However, many women who were part of No Surrender, were not so lucky. Their triple negative tumors were found too late. African American women were the majority of this group, and unfortunately, they are all gone now.

As you know, because Komen has published some of the studies, African American women disproportionately develop TNBC at a younger age. This is also true of Hispanic women and women of Ashkenazi Heritage. The current standard of screening is for women to get their first mammogram at age 40 or older. This can have deadly consequences to a young woman who has a TNBC tumor...they need to get formally screened before the age of forty...

The Before Forty Initiative is empowering, educational and ultimately, will save the lives of young, African American and other high risk women. ”

Their response?

Your project, “Before Forty Initiative” is not eligible for funding because Susan G. Komen for the Cure’s current screening guidelines are not in line with what your organization promotes.

And thus endeth the lesson.

They state on their own site that African American women get TNBC young. They say they are "fighting for us," and have raised billions of dollars for the "fight against breast cancer." But when a program as simple and pure as early screening and education about the most aggressive form of breast cancer that is attacking and killing young women asks for funding, it is denied because they believe women should not be screened until after the age of forty. Does that sound like they are fighting for you?

I ask you, my readers, fellow breast cancer warriors, friends, and supporters, the next time you sit down to write a check to the Pink, consider helping us save lives instead. We need your help and we need it now and so do the young women out there who don't even know what TNBC is and don't know that they should get checked out now, before it is too late to help them.

You see, we believe in what we promote and we promote what we believe. 100% of your donations go to helping women with breast cancer.

I made a promise to Ferne and to Lori and to Steph and to Lisa and to Vicki and to over twenty other young, beautiful women who lost their lives to TNBC because their cancer was found too late. I take my promises seriously and I will never, ever back down, I will never lose my focus and I will fight for us forever.

An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months, whole breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (P = .02; hazard ratio 0.8) and distant recurrence from 13% to 7.6% (P = .002; HR 0.64), lead investigator Dr. Timothy Whelan reported at the annual meeting of the American Society of Clinical Oncology.

Overall survival in the intergroup trial was 9.3% with WBI vs. 7.7% with the combined radiation regimen, but the difference did not reach statistical significance (P = .07; HR 0.76).
In view of the positive findings, the data safety monitoring committee recommended that the results be released, Dr. Whelan told reporters at a press briefing during the meeting.

He suggested that the findings could expand the pool of women offered RNI. Currently, ASCO and the American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines recommend locoregional radiation following mastectomy for tumors greater than 5 cm or with more than three positive axillary nodes.

Of the 1,832 women enrolled in the National Cancer Institute of Canada Clinical Trials Group MA.20 trial, 85% had one to three positive lymph nodes, and 10% had high-risk, node-negative breast cancer. All women were treated with breast-conserving surgery plus adjuvant chemotherapy or endocrine therapy.

"Results from MA.20 suggest that all women with node-positive disease be offered regional node irradiation provided they are made aware of the associated toxicities," said Dr. Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ont.
The addition of RNI to WBI significantly increased the rates of grade 2 or higher dermatitis from 40% to 50% (P less than .001), pneumonitis from 0.2% to 1.3% (P = .01), and lymphedema from 4% to 7% (P = .004). The lymphedema was primarily grade 2, Dr. Whelen pointed out.

Reporters questioned why an earlier unpublished French study did not find a benefit with RNI, while MA.20 did. Dr. Whelan responded that regional radiation in the earlier study was limited to the internal mammary lymph nodes alone, whereas MA.20 expanded the upper radiation field to include the upper internal mammary nodes, supraclavicular nodes, and high axillary nodes. He could not explain why overall survival was not improved.

Radiation dosages for WBI were 50 Gy in 25 fractions plus a boost at the discretion of the cancer center of 10 Gy in 5 fractions. The RNI dosage was 45 Gy in 25 fractions.

WBI and RNI were delivered concurrently, so the added therapy would not require additional office visits for women, and would modestly lengthen the therapy.

The researchers will continue to monitor the patients and evaluate new techniques to reduce potential side effects, he said in an interview.

MA.20 was sponsored by the Canadian Cancer Society Research Institute, National Cancer Institute/Cancer Therapy Evaluation Program, and Canadian Breast Cancer Research Alliance. Dr. Whelan and his coauthors disclosed no conflicts of interest.

Support Our Foundation

Welcome

The No Surrender Breast Cancer Foundation is here to help every woman who has ever been touched by breast cancer. We offer a 24/7 peer driven support forum, it is by survivor for survivor - for you.
Our comprehensive website has everything you need to learn about your cancer so you can make the best decisions for your care. We offer the latest information on surgery, reconstruction, chemotherapy, hormonal therapy and radiation and, most important, how to live the best life after breast cancer, because yes, there is life after cancer!
Our programs are designed to save lives through early detection, self advocacy, and changing the standard of care so that women can protect themselves.
For more information, please visit our website to learn about No Surrender Breast Cancer Foundation... hope happens here!